Global Regulatory Affairs Principal Leader – Medical Devices
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Quality Assurance - QA/QC
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Healthcare
Job Description & How to Apply Below
Werfen is seeking a Senior Principal Regulatory Affairs Specialist to support regulatory affairs and quality systems for US, Canada, and EU markets. You will drive submissions (510(k), BLA), maintain technical files, and ensure compliance across global regulatory requirements.
The ideal candidate has 8+ years in medical device regulatory affairs, with strong knowledge of FDA and EU regulations, ISO 13485, and risk management frameworks.
This posting is for the Global Regulatory Affairs Principal Leader – Medical Devices role at Werfen, based in Norcross, GA, United States.
Join Werfen and contribute to our ongoing work.
Take a moment to read everything above and see whether this role is right for you.
We are looking to fill the Global Regulatory Affairs Principal Leader – Medical Devices position at Werfen in Norcross, GA, United States.
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